Table 1 Schedule of assessments, instruments, and procedures to be implemented at each study appointment
Variable | Instrument | Week (first row) Appointment number (second row) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
− 2 | 0 (baseline) | 2 | 4 | 6 | 8 | 26 | ||||||
1a | 1b | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||
Screening (via Telehealth) | ||||||||||||
 Enrolment | Informed consent | ✓ | ||||||||||
 General inclusion criteria | Eligibility screener for entrance criteria | ✓ | ||||||||||
 Alcohol and substance abuse | Alcohol Use Disorders Identification Test (AUDIT) Drug Abuse Screening Test (DAST-10) | ✓ | ||||||||||
 Diagnosis of MDD | Structured Clinical Interview for the DSMI-V (SCID-V) mood disorders module | ✓ | ||||||||||
 Depression severity and suicidality | Montgomery-Asberg Depression Rating Scale (MADRS) | ✓ | ||||||||||
Study appointments | ||||||||||||
 Group allocation | Randomisation spreadsheet | ✓ | ||||||||||
 FMT | Enema-delivery of intervention or placebo | ✓ | ✓ | ✓ | ✓ | |||||||
 Demographics | General questionnaire | ✓ | ||||||||||
 Medical history | Medical history Standard psychiatric assessment Family history | ✓ (optional) | ✓ | |||||||||
Study appointments continued. | ||||||||||||
 Medication use | Current medications Medication history | ✓ | ✓ | |||||||||
 Personality disorders | Personality disorders (SAPAS) | ✓ | ||||||||||
Diet | Diet (Simple Dietary Questionnaire) | ✓ | ✓ | |||||||||
 Psychological symptoms | Depression, Anxiety and Stress symptomatology (DASS) Depression severity (MADRS) Suicidality (MADRS) | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
 Gut symptoms | Gastrointestinal Symptom Rating Scale (GSRS) | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
 Medical variables | Change in medications, vaccines, illness, etc | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
 General health and functioning | Patient Global Impression of Change Sheehan Disability Scale Sleep (Pittsburgh Sleep Quality Index) Quality of Life | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
Study appointments continued. | ||||||||||||
 Changes of circumstance | Medication changes questionnaire | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
 Cost analysis | Resource Utilisation Questionnaire | ✓ | ✓ | |||||||||
 Physical examination | Height (stadiometer) Weight (scales) Blood pressure (sphygmomanometer) Heart rate (sphygmomanometer) | ✓ | ✓ | ✓ | ||||||||
 Blood samples | Whole blood by research nurse/ACL | ✓ | ✓ | ✓ | ||||||||
 Stool samples | Microba stool collection kits | ✓ | ✓ | ✓ | ||||||||
Feasibility data | ||||||||||||
 Tolerability | Adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
 Adequacy of blinding | Participant questionnaire | ✓ | ||||||||||
 Adherence | Monitoring questionnaire completion and appointment attendance throughout the study period | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
 Acceptability | Study Participant Feedback Questionnaire Specific questions pertaining to study intervention | ✓ | ✓ | ✓ | ||||||||
Researcher/trial feasibility data | ||||||||||||
 Recruitment | Monitoring of recruitment rates by study staff throughout trial period | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||
 Retention | Monitoring of trial attrition by study staff throughout trial period | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||